MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC ME1000 BROACH-ADAPTER-STRAIGHT; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 1010-01-101

Device Problems Detachment of Device or Device Component (2907); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The date of manufacture was not available.The actual device has been returned and is currently pending evaluation.Once the evaluation has been completed, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during service and repair pre-testing, it was discovered that the broach-adapter device did not hold the actis broach device securely.It was further reported that when locked, the actis broach moved in multiple directions and it felt loose.The event was not related to surgery.There was no patient involvement.There were no injuries or medical intervention associated with this event.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The device manufacture date was reported as unknown in the initial medwatch.The date of manufacture has been updated to sep 26, 2017.The actual device was returned without an alleged deficiency.During routine service and repair of the device, it was observed that the broach adapter did not hold the actis broach securely, when locked the actis broach moved in multiple directions and felt loose.The broach did move when latched into the adapter, however no defect was found.It was determined that the movement is normal from wear of the adapter over time and does not affect the functionality of the adapter and broach.A review of the device history was performed and no non-conformances were detected related to the reported condition.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: ME1000 BROACH-ADAPTER-STRAIGHT
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8371009
• MDR Text Key: 137242883
• Report Number: 1045834-2019-52979
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00850915006037
• UDI-Public: 850915006037
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1010-01-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACTIS BROACH DEVICE